Senior Regulatory Compliance OfficerOur client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released.

Responsibilities• Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant departments• Manage the preparation, review and approval of Manufacturing and Analytical records and approval of External product documentation, in accordance with registered details• Problem solving of regulatory compliance issues and implementation of CAPA’s arising from these• Management of the compliance systems and implementation of improvement projects where necessary• Coordinate the MRA Reduced Testing and Annex 16 Programmes• Manage the Product Transfer and Product Launch compliance activities• Manage change control and the registration variation process• Track variations and maintain the variation tracker database identifying and addressing gaps in the system• Liaise with central registration department to develop systems which help to improve the compliance systems and information received• Manage site projects from a Regulatory Compliance perspective• Mentor and train Regulatory Compliance officers• Manage Reg Compliance actions for Launch and 3rd party requirements

Requirements• 3rd level qualification in science related discipline• 3 - 5 years’ experience within the pharmaceutical industry• Relevant experience in regulatory or regulatory compliance group in a GMP/GLP environment is desirable• Strong organizational skills / ability to prioritize work• Proven track record as a team player• High level of proficiency in Microsoft Word/Excel

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